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Capital, M&A & Industry Strategy2 weeks agoChina’s IIT overhaul has narrowed access and raised standards
BIOCENTURY | PRODUCT DEVELOPMENTCHINA’S IIT OVERHAUL HAS NARROWED ACCESS AND RAISED STANDARDSInvestigators report a sharp drop in study approvals under Order 818 but see benefits for...
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Global Biotechnology & Pharmaceutical Markets2 weeks agoTigermed’s take on running trials in the U.S. and China
BIOCENTURY | PRODUCT DEVELOPMENTTIGERMED’S TAKE ON RUNNING TRIALS IN THE U.S. AND CHINABritney Winterberger on parallel U.S.-China development strategies, IITs, and easing friction in clinical development
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Regulatory Intelligence & Drug Approvals2 weeks agoGSK’s Jemperli gains rectal cancer approval as rivals advance across colorectal settings
BIOCENTURY | PRODUCT DEVELOPMENTGSK’S JEMPERLI GAINS RECTAL CANCER APPROVAL AS RIVALS ADVANCE ACROSS COLORECTAL SETTINGSSurgery-sparing treatment gains accelerated approval as ESMO data broaden the evidence for...
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Global Biotechnology & Pharmaceutical Markets2 weeks agoChina is growing its first-in-class footprint
BIOCENTURY | DATA BYTECHINA IS GROWING ITS FIRST-IN-CLASS FOOTPRINTMore than 40% of China’s deals this year are for programs with first-in-class potential, the highest share in...
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Capital, M&A & Industry Strategy2 weeks agoIronwood promoting commercial chief in planned CEO succession
BIOCENTURY | MANAGEMENT TRACKSIRONWOOD PROMOTING COMMERCIAL CHIEF IN PLANNED CEO SUCCESSIONPlus: Former Novo CEO to become Lundbeck’s chair; FDA official takes position amid BetaNova merger; and...
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Synthetic Biology, Genomics & Advanced Therapeutics2 weeks agoStoffels turns to Indian pharma to revive CAR T programs
BIOCENTURY | FINANCESTOFFELS TURNS TO INDIAN PHARMA TO REVIVE CAR T PROGRAMSMankind’s majority investment backs start-up Armed Cell amid weak VC appetite for cell therapy companies
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Global Biotechnology & Pharmaceutical Markets2 weeks agoChina trends; Roche, Merck KGaA deals; Arrowhead and tau — a BioCentury podcast
BIOCENTURY | DEALSCHINA TRENDS; ROCHE, MERCK KGAA DEALS; ARROWHEAD AND TAU — A BIOCENTURY PODCASTTrends to watch in China — from IITs to earlier deals
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Capital, M&A & Industry Strategy2 weeks agoHansoh’s Weiyong Sun: Roche deal part of strategy to capture more upside
BIOCENTURY | PRODUCT DEVELOPMENTHANSOH’S WEIYONG SUN: ROCHE DEAL PART OF STRATEGY TO CAPTURE MORE UPSIDECBO Sun on dealmaking, Hansoh’s strategy, and what’s ahead for the China...
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Capital, M&A & Industry Strategy2 weeks agoRoche-Hansoh co-development deal lands amid debate over China restrictions
BIOCENTURY | POLITICS, POLICY & LAWROCHE-HANSOH CO-DEVELOPMENT DEAL LANDS AMID DEBATE OVER CHINA RESTRICTIONSTreasury could release draft COINS rule, controls on outbound biotech investments, this week
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Clinical Trials & Development2 weeks agoDisc’s Phase III win addresses FDA’s concerns about bitopertin’s efficacy
BIOCENTURY | PRODUCT DEVELOPMENTDISC’S PHASE III WIN ADDRESSES FDA’S CONCERNS ABOUT BITOPERTIN’S EFFICACY BioCentury’s Clinical Report, October 13-19
Widespread atropine use fails to sway FDA advisors on Sydnexis data
At least 11 PDUFAs on FDA’s November docket
FDA Grants Accelerated Approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for Recurrent Respiratory Papillomatosis
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
